Director, Clinical Operations - #262068

POSITION SUMMARY:

ALX Oncology seeks a dynamic leader with a proven track record of success in Clinical Operations. Reporting to the Senior Vice President, Clinical Operations, the Director, Clinical Operations will guide the clinical team to achieve all milestones and deliverables from protocol creation to study completion. The candidate will actively participate in developing and executing on the clinical trial strategy in support of the Clinical Development Plan, and to work across departments to ensure that studies are planned and conducted efficiently and with the highest quality. The Director will manage cross-functional activities in order to ensure that clinical study goals are met on time and within budget.

PRIMARY RESPONSIBILITIES AND DUTIES:

• Provide strategic direction for outsourcing, selection, and oversight of CROs, and provide ongoing executive management to selected partners.
• Develop and continuously monitor study timelines, study progress, study costs, and resource allocations. Implement corrective action when deviations occur; work with functions to develop contingency plans and drive their implementation when triggered.
• Oversee the preparation and management of clinical trial budgets. Support Finance and Corporate Development to forecast estimated costs for potential studies. Liaison with Clinical and Finance teams to review CRO budgets, change orders, invoices, and to approve payments.
• Oversee one or more clinical studies, including coordination of internal cross-functional team and external partners
• Work with internal team members and CROs in the identification, evaluation and selection of clinical trial investigators and sites, including cooperative groups in multi-center trials as well as in investigator-initiated studies.
• Interact collaboratively with Quality, Regulatory, CMC, Finance, and Clinical teams to ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
• Support development of SOPs and establishment of associated training for teams, and ensure consistency, quality and compliance with global clinical standards.
• Develop, manage and report study metrics and KPIs, including reporting to senior management
• Oversee one or more direct reports including performance management and professional development
• Other duties as assigned.
  
  
  

QUALIFICATIONS AND SKILLS:

• Bachelor of Science degree with ten plus (10+) years’ experience; MS/RN with eight plus (8+) years’ experience.
• Broad and deep knowledge of Clinical Operations, Clinical Development, and Clinical Project Management.
• Experience with CRO Management.
• Working knowledge of ICH/GCP guidelines.
• Effective written/verbal communication.
• Ability to work independently as well as collaboratively in a multidisciplinary setting.
• Flexibility and willingness to adapt in a changing environment.
• Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home).
  
  
  

SALARY RANGE: $215,000 - $230,000 DOE

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

ALX Oncology is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

About Alx Oncology

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, Evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action.

For more information about us, please visit www.alxoncology.com .